Status:
COMPLETED
Study on the Incidence of Intussusception (IS) in Children Aged < 12 Months in Japan
Lead Sponsor:
GlaxoSmithKline
Conditions:
Intussusception
Eligibility:
All Genders
Up to 12 years
Brief Summary
This study aims to analyse baseline data on IS in order to monitor the possibility of increased risk of IS in children aged \<12 months after introduction of the Rotarix vaccination in Japan.
Eligibility Criteria
Inclusion
- A male or female infant aged \< 12 months at the time of IS diagnosis and affiliated to the JMDC-MDB database.
- An IS case should be identified as per the ICD-10 diagnostic code-K56.1 (any-field listed), examination codes, and procedural codes.
Exclusion
- Not applicable
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01479491
Start Date
November 1 2011
End Date
November 1 2011
Last Update
October 22 2012
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